An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT02497469|
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colitis, Ulcerative||Drug: Vedolizumab Drug: Adalimumab placebo Drug: Adalimumab Drug: Vedolizumab placebo||Phase 3|
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis. This study will look at the stool frequency, rectal bleeding and findings on endoscopy of people who take vedolizumab compared to those who take adalimumab.
The study will enroll approximately 658 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Vedolizumab 300 mg IV
- Adalimumab 160 mg on Day 1 followed by 80 mg on Week 2 then 40 mg every 2 weeks SC
All participants will receive 1 intravenous infusion on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. All participants will also receive 4 SC injections on Day 1 or 2 SC injections each on Days 1 and 2, followed by 2 SC injections in 1 day on Week 2 and then 1 SC injection every 2 weeks for up to Week 50. All participants will be asked to record the symptoms of ulcerative colitis in a daily diary.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is 79 weeks. Participants will make approximately 11 visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||770 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis|
|Actual Study Start Date :||July 15, 2015|
|Actual Primary Completion Date :||September 26, 2018|
|Actual Study Completion Date :||January 18, 2019|
Experimental: Vedolizumab IV
Vedolizumab 300 milligram (mg), infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
Drug: Adalimumab placebo
Adalimumab placebo-matching injection
Active Comparator: Adalimumab SC
Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
Drug: Vedolizumab placebo
Vedolizumab placebo-matching infusion
- Percentage of Participants Achieving Clinical Remission [ Time Frame: Week 52 ]Clinical remission is defined as a complete Mayo score of less than or equal to (<=) 2 points and no individual subscore greater than (>) 1 point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consists of 4 subscores: stool frequency, rectal bleeding, findings of endoscopy, and physician global assessment, each ranges from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).
- Percentage of Participants Achieving Mucosal Healing [ Time Frame: Week 52 ]Mucosal healing is defined as Mayo endoscopic subscore <=1 point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Findings of endoscopy is a subscale of Mayo score, which ranges from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).
- Percentage of Participants Using Oral Corticosteroids at Baseline who Discontinue Corticosteroids and are in Clinical Remission [ Time Frame: Week 52 ]Corticosteroid-free remission: participants who discontinue corticosteroids and achieve clinical remission will be assessed in participants with baseline oral corticosteroid use. Clinical remission is defined as a complete Mayo score of <=2 points and no individual subscore >1 point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consists of 4 subscores: stool frequency, rectal bleeding, findings of endoscopy, and physician global assessment, each ranges from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497469
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|Study Director:||Medical Director||Takeda|